The document discusses two investigator-initiated studies funded by the National Heart, Lung, and Blood Institute (NHLBI). The first story describes a study that found reopening occluded arteries in patients who had a heart attack over 24 hours prior did not reduce risk of death or heart attack and was difficult to conduct due to physician bias in favor of the procedure and slow funding and recruitment. The second story discusses a study that found certain blood thinning drugs can prevent heart attacks and strokes, despite initial resistance from the medical community. The document advocates for continued government funding of investigator-initiated clinical trials to evaluate new treatments while managing conflicts of interest.

1. Investigator-Initiated Studies: Two Stories from the NIH Michael S Lauer, MD, FACC, FAHA Director, Division of Cardiovascular Sciences NHLBI/NIH January 11, 2012 Disclosures: None

2. First Story: Occluded Artery after MI http://www.circulation.or.kr/info/case/200904/fig1.gif http://www.indiastudychannel.com/attachments/Resources/82666-221135-Coronary%20Angiogram.jpg

3. Observational Findings Lamas GA et al. Circulation 1995;92:1101-9

4. OAT Timeline 9/30/99 OAT Starts 6/15/98-8/02/99 OAT Pilot enrollment 12/30/05 OAT Recruitment Completed Total: 2166 07/2001 TOSCA-2 begins 08/2002 OAT-EP begins 12/2003 OAT-NUC begins AHA 6/1/1998 1st NHLBI submission 3/1/1999 2nd NHLBI submission NHLBI Workshop on Coronary Revascularization 1st OAT Steering Committee 151 409 485 523 382 196 Enrolled patients per year 20 Many thanks to Dr. Judith Hochman 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

8. The Findings and Response ACC/AHA STEMI Guideline: “PCI of a totally occluded infarct artery greater than 24 hours after STEMI is not recommended in asymptomatic patients…[who] do not have evidence of severe ischemia.” Hochman JS. N Engl J Med 2006;355:2395-407 Antman EM et al. JACC 2008;51:210-47

9. A More Recent Story Ridker PM. J Throm Haemost 2009;7(S 1):332-9 Ridker PM et al. N Engl J Med 2008;359:2195-207